Orthodontic ApplianceMiniscrewNCT05092633
Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement
A study testing Miniscrew in people with Orthodontic Appliance, run by Alexandria University at 2 sites in Egypt.
Trial summary
EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- Miniscrew
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesEgypt
- Study dates
- 26 Sep 2021to 5 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 to 22 years old.
- Permanent dentition.
- Class I Bimaxillary protrusion and class II devision 1 patients.
- Good oral hygiene.
Who cannot join
- Medically compromised patients.
- Chronic renal failure and hormonal disorders as thyroid and parathyroid.
- Regular use of steroids, barbiturates, anticonvulsants drugs, and thyroid hormone replacements.
- Tobacco smoking.
- Any disease or metabolic disorder that can affect bone physiology
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Alexandria University
Alexandria
Mohamed A Elzoheiry, 01007036198, dr.melzoheiry@gmail.com
- Recruiting
AlexandriaU
Alexandria
Mohamed Elzoheiry, 01007036198, Dr.melzoheiry@gmail.com
About this study
EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT
Read the detailed description
Miniscrews can achieve good anchorage for different types of tooth movements, as intrusion, retraction, and protraction. However, obtaining primary stability is a challenge in their clinical application.Low Level Laser Therapy is suggested to prevent miniscrew displacement. Also previous studies concluded that Low Level Laser Therapy has an effect in stabilizing miniscrew after direct application.
So the aim of this study is to assess the effect of Low Level Laser Therapy on displacement of miniscrews during canine retraction.
- Conditions
- Orthodontic Appliance
- Being tested
- Miniscrew
- Keywords
- Miniscrew
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniscrewDevice
Also called Laser
Application of laser on miniscrew
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Will have miniscrew only without laser application Receives: Device: Miniscrew |
| Experimental | Experimental | Will have miniscrew and laser application Receives: Device: Miniscrew |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of low level laser therapy on displacement of miniscrews
Miniscrews displacement will be assessed after four months of canine retraction using CBCT scan. The head and tail of miniscrew will be measured in relation to anterior nasal spine as a fixed reference point before and after retraction
Measured: 4 months
Secondary outcomes (1)
effect of LLL application on gingival condition around the miniscrew.
Gingival inflammation around miniscrew head will evaluated just after placement and at day 7 and 14 before application of retraction force and during days 21, 30, 60 which will be during the period of force application, based on modified gingival index with scores range from 0 to 3 as follows:Score 0 - no signs of inflammation (tissue around head is pink in color).
Score 1 - mild inflammation (tissues are red in color, no bleeding sign). Score 2 - moderate inflammation (tissues are intense red in color, small bleeding signs).
Score 3- severe inflammation (bleeding, evidence of swelling).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start26 Sep 2021
- Primary completion7 Apr 2022 (estimated)
- Study completion5 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic ApplianceStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elzoheiry, Alexandria University
- Investigators
- Mohamed A Elzoheiry, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092633
- Sponsor's protocol ID
- Effect of laser on mini screw
- Acronym
- Miniscrew
- Status last verified
- Nov 2021
- First submitted
- 27 Sep 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement
- ClinicalTrials.gov ID
- NCT05092633
- Acronym / sponsor ID
- Miniscrew / Effect of laser on mini screw
- Conditions
- Orthodontic Appliance
- Keywords
- Miniscrew
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 7 Apr 2022 (estimated)
- Study completion
- 5 May 2022 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT
Detailed description
Miniscrews can achieve good anchorage for different types of tooth movements, as intrusion, retraction, and protraction. However, obtaining primary stability is a challenge in their clinical application.Low Level Laser Therapy is suggested to prevent miniscrew displacement. Also previous studies concluded that Low Level Laser Therapy has an effect in stabilizing miniscrew after direct application.
So the aim of this study is to assess the effect of Low Level Laser Therapy on displacement of miniscrews during canine retraction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: MiniscrewWill have miniscrew only without laser application |
| Experimental | Experimental | Device: MiniscrewWill have miniscrew and laser application |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 22 years old.
- Permanent dentition.
- Class I Bimaxillary protrusion and class II devision 1 patients.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Medically compromised patients.
- Chronic renal failure and hormonal disorders as thyroid and parathyroid.
- Regular use of steroids, barbiturates, anticonvulsants drugs, and thyroid hormone replacements.
- Tobacco smoking.
- Any disease or metabolic disorder that can affect bone physiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniscrewAlso: LaserApplication of laser on miniscrew | Device | Control, Experimental |
Primary outcome
effect of low level laser therapy on displacement of miniscrews
Time frame: 4 months
Miniscrews displacement will be assessed after four months of canine retraction using CBCT scan. The head and tail of miniscrew will be measured in relation to anterior nasal spine as a fixed reference point before and after retraction
1 secondary outcome
effect of LLL application on gingival condition around the miniscrew.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Elzoheiry study director
Alexandria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miniscrew in people with Orthodontic Appliance, run by Alexandria University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Elzoheiry (01007036198, dr.melzoheiry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of low level laser therapy on displacement of miniscrews (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.